Methods of molding intraocular lenses

ABSTRACT

Intraocular implants and methods of making intraocular implants are disclosed. The intraocular implant can include a mask adapted to increase depth of focus. The method of manufacturing the implant can include filling an annular mask-forming trough with an opaque mask material and adding an optically transmissive optic material over the opaque mask material.

RELATED APPLICATIONS

This application claims priority benefit of U.S. Patent Application No.62/237,429, filed Oct. 5, 2015, which is hereby incorporated byreference in its entirety herein.

BACKGROUND Field

This application relates generally to the field of intraocular devices.More particularly, this application is directed to intraocular implantsand lenses (IOLs) with an aperture to increase depth of focus (e.g.,“masked” intraocular lenses), and methods of making the same.

Description of the Related Art

The human eye functions to provide vision by transmitting and focusinglight through a clear outer portion called the cornea, and furtherrefining the focus of the image onto a retina by way of a crystallinelens. The quality of the focused image depends on many factors includingthe size and shape of the eye, and the transparency of the cornea andthe lens.

The optical power of the eye is determined by the optical power of thecornea and the crystalline lens. In a normal, healthy eye, sharp imagesof distant objects are formed on the retina (emmetropia). In many eyes,images of distant objects are either formed in front of the retinabecause the eye is abnormally long or the cornea is abnormally steep(myopia), or formed in back of the retina because the eye is abnormallyshort or the cornea is abnormally flat (hyperopia). The cornea also maybe asymmetric or toric, resulting in an uncompensated cylindricalrefractive error referred to as corneal astigmatism.

Some people suffer from cataracts in which the crystalline lensundergoes a loss of transparency. In such cases, the crystalline lenscan be removed and replaced with an intraocular lens (IOL). However,some intraocular lenses may still leave defects in a patient'snon-distance eyesight.

SUMMARY

Methods of manufacturing masked intraocular lenses can include a moldingprocess. In general, the molding process can include pouring an uncuredmaterial into a mold and then curing the material with a combination ofUV light and heat temperature cycles. However, when performing a moldingprocess with both optically transmissive and opaque materials (e.g., anoptically transmissive optic material and an opaque mask material), itcan be difficult to produce precise border lines between the optic andthe aperture, which can reduce the optical performance of theintraocular lens.

The present disclosure is generally related to methods of manufacturinga masked intraocular lens with an annular mask embedded within orpositioned on an anterior or a posterior surface of the optic. The maskand the optic may comprise the same material, such as an acryliccopolymer or silicone. The methods disclosed herein produce a preciseborder line at the interface between inner and outer diameters of themask and the optic.

The method of manufacturing the intraocular lens can include filling anannular mask-forming feature (e.g., a trough) with an opaque maskmaterial, adding optically transmissive optic material over the opaquemask material; and fully curing the opaque mask material and theoptically transmissive optic material to form a mask and an optic. Themask can be sufficiently thick to prevent transmission of at least 90%of incident visible light (or at least about 98% of incident visiblelight). The annular mask-forming feature can be provided in a lens moldor in a partially-formed optic.

Any feature, structure, or step disclosed herein can be replaced with orcombined with any other feature, structure, or step disclosed herein, oromitted. Further, for purposes of summarizing the disclosure, certainaspects, advantages, and features of the inventions have been describedherein. It is to be understood that not necessarily any or all suchadvantages are achieved in accordance with any particular embodiment ofthe inventions disclosed herein. No aspects of this disclosure areessential or indispensable.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

FIG. 1A illustrates an embodiment of a mask.

FIG. 1B illustrates another embodiment of the mask.

FIGS. 2A-2D illustrate an embodiment of an intraocular lens having amask positioned on an anterior surface of the optic.

FIGS. 3A-3D illustrate another embodiment of an intraocular lens havinga mask positioned on a posterior surface of the optic.

FIGS. 4A-4D illustrate yet another embodiment of an intraocular lenshaving a mask embedded in the optic.

FIG. 5 is a flow chart of a method of manufacturing an intraocular lenswith a mask positioned on a surface of the optic.

FIG. 6 is a flow chart of a method of manufacturing an intraocular lenswith a mask embedded in the optic.

FIG. 7 is a flow chart of another method of manufacturing an intraocularlens within a mask embedded in the optic.

FIGS. 8A-8E illustrate different embodiments of a mold delineator.

FIGS. 9A-9F illustrate a method of manufacturing an intraocular lensusing the steps shown in FIG. 7.

DETAILED DESCRIPTION

Patients who undergo intraocular lens (IOL) implantation surgery maystill suffer from defects in their non-distance eyesight (e.g.,presbyopia). One technique for treating such defects is by including anannular mask within or on the optic that increases the patient's depthof focus. The light rays that pass through the aperture in the maskconverge at a focal point on the retina, while the light rays that wouldnot converge at the focal point on the retina are blocked by an opaqueportion of the mask configured to prevent at least some or substantiallyall visible light from being transmitted through the mask.

Mask

FIG. 1A illustrates a mask 2034 a having an annular region 2036 asurrounding an aperture 2038 a substantially centrally located on themask 2034 a. An anterior surface of the annular region 2036 a can have acurvature from the outer periphery to the inner periphery of the annularregion 2036 a, and the posterior surface of the annular region 2036 acan have a similar curvature. However, as shown in FIG. 1B, the mask2034 b can also be flat. The mask 2034 b can include an annular region2034 b surrounding an aperture 2038 b substantially centered on theoptical axis 2039 b of the mask 2034 b. Although the features describedbelow are described with respect to the mask 2034 a, one or the more ofthe features may be applied to the mask 2034 b.

In some embodiments, the outer periphery of the mask 2034 a is generallycircular with an outer diameter of at least about 3 mm and less thanabout 6 mm. In some embodiments, the diameter of the outer periphery ofthe mask 2034 a is at least about 3 mm and less than or equal to about 4mm.

A thickness of the mask 2034 a can be constant or can vary between theinner periphery (near the aperture) and the outer periphery. Forexample, the thickness may increase from an outer periphery and/or innerperiphery of the mask 2034 a and toward a radial midline of the annularregion 2036 a. In general, the thickness at any location of the mask2034 a can be less than or equal to about 200 microns, or less than orequal to about 100 microns, but preferably between about 1 micron andabout 20 microns. For example, the thickness of the mask 2034 a can bewithin the range: from about 1 micron to about 40 microns, from about 5microns to about 20 microns, from about 5 microns to about 15 microns.In some implementations, the thickness of the mask 2034 a can be withinabout two microns of: about 15 microns, about 10 microns, about 8microns, or about 5 microns.

The aperture 2038 a can transmit substantially all incident visiblelight along the optical axis 2039 a. For example, the aperture 2038 acan be a through-hole in the annular region 2036 a or a substantiallylight transmissive (e.g., transparent to visible light) portion thereof.The aperture 2038 a can be substantially circular and/or substantiallycentered around the optical axis 2039 a of the mask 2034 a. The size ofthe aperture 2038 a can be any size that is effective to increase thedepth of focus of an eye of a patient with presbyopia. In particular,the size of the aperture 2038 a can be dependent on the location of themask within the eye (e.g., distance from the retina). In someimplementations, the aperture 2038 a can have a diameter of at leastabout 0.85 mm and less than or equal to about 2.2 mm, at least about 1.1mm and less than or equal to about 1.6 mm, or at least about 1.3 mm andless than or equal to about 1.4 mm.

The annular region 2036 a can prevent transmission of substantially allor at least a portion of the spectrum of the incident visible light(e.g., radiant energy in the electromagnetic spectrum that is visible tothe human eye) and/or the spectrum of non-visible light (e.g., radiantenergy outside the range visible to humans). Preventing transmission ofvisible light through the annular region 2036 a can block light thatwould not converge at the retina and fovea to form a sharp image. Insome implementations, the annular region 2036 a can prevent transmissionof at least about: 90 percent of incident visible light, 92 percent ofincident visible light, 95 percent of incident visible light, 98 percentof all incident visible light, or 99 percent of all incident visiblelight. In other words, the annular region 2036 a can transmit no morethan about: 10 percent of incident visible light, 8 percent of incidentvisible light, 5 percent of incident visible light, 3 percent ofincident visible light, 2 percent of incident visible light, or 1percent of incident visible light.

In some embodiments, opacity of the annular region 2036 a is achievedbecause the material used to make mask 2034 a is naturally opaque. Inother embodiments, the material used to make the mask 2034 a may benaturally substantially clear but treated with a dye or otherpigmentation agent (e.g., carbon black).

Further variations of masks can be found in U.S. Pat. No. 7,628,810,filed May 26, 2004, U.S. Publication No. 2012/0143325, filed Feb. 19,2012, U.S. Publication No. 2011/0040376, filed Aug. 13, 2010; U.S.Publication No. 2013/0268071, filed Nov. 30, 2012; U.S. Publication No.2014/0264981; U.S. Publication No. 2015/0073549, filed Aug. 7, 2014;U.S. Pat. No. 5,662,706, filed Jun. 14, 1996; U.S. Pat. No. 5,905,561,filed Jun. 14, 1996; and U.S. Pat. No. 5,965,330, filed Dec. 6, 1996,all of which are included in the Appendix.

Intraocular Lens

As shown in FIGS. 2A-2D, the intraocular lens 1000 includes an optic1004 and a mask 1012. The optic 1004 can be formed from an opticallytransmissive material, while the mask can be formed from an opaquematerial.

The optic 1004 may be monofocal or multifocal and it can have positiveor negative optical power. The optic 1004 may be aspheric or any otherconfiguration as the context may dictate. In some implementations, thegreatest thickness of the optic 1004 is at the center of the optic 1004.In other implementations, the optic 1004 may have a reduced thickness atits center, which is further described in U.S. Publication No.2011/0040376, filed Aug. 13, 2010, and is included in the Appendix. Theoptic 1004 may be substantially circular with an outer diameter betweenabout 5.0 mm and about 8.0 mm, such as about 6.0 mm. A central thicknessof the optic 1004 can be less than or equal to about 1.0 mm, such asbetween about 0.75 mm and about 1.0 mm.

The intraocular lens 1000 may include one or more haptics 1008 (e.g.,one, two, three, four, or more) to prevent the intraocular lens 1000from moving or rotating within the eye. As used herein the term “haptic”is intended to be a broad term encompassing struts and other mechanicalstructures that can be apposed against an inner surface of an eye andmounted to an optic to securely position an intraocular lens in anoptical path of an eye. The haptics 1008 can be a variety of shapes andsizes depending on the location the intraocular lens 1000 is implantedin the eye. The haptics 1008 may be C-shaped, J-shaped, plate design, orany other design. The haptics 1008 may be manufactured substantiallyflat or vaulted with respect to the optic. Variations on the shape ofthe optic and the haptics can be found in U.S. Publication No.2011/0040376, filed Aug. 13, 2010, which is included in the Appendix.

The mask 1012 can be formed on an anterior surface 1016 of the optic1004 (see FIGS. 2A-2D), on a posterior surface 1020 of the optic 1004(see FIGS. 3A-3D), or embedded within the optic 1004 (see FIGS. 4A-4D).When the mask 1012 is embedded within the optic 1004, the mask 1012 canbe formed substantially at the midway line between the posterior 1020and anterior surfaces 1016 of the optic 1004. But the mask 1012 can alsobe formed at other locations within the optic 1004.

Methods of Manufacturing

In some embodiments, the optic 1004 can be formed by molding a liquidlens material, such as an acrylic or silicone material, and curing thematerial into a solid. A completed solid mask 1012 can bepre-manufactured (e.g., from a different material than the optic) andpositioned on or in the optic as part of this molding process. However,in this type of process where the mask 1012 is pre-manufactured and thenmolded into the optic, there is a potential for an inadequate bondbetween the mask and the optic. In addition, if the mask and the opticare made of different materials, there is a potential that the opticalperformance of the intraocular lens can be compromised due to the maskand optic materials potentially having elasticities and/or thermalexpansion properties, which are too dissimilar. For example, if thematerial properties of the optic 1004 and the mask 1012 are notadequately compatible, then deformations, such as those resulting frominjection forces during surgical implantation or swelling that may occurduring manufacture due to chemical extractions, may damage theintraocular lens. Similarly, temperature shifts that occur duringmanufacture and/or surgical implantation can also damage the intraocularlens.

It can therefore be advantageous to manufacture the intraocular lensusing a process where the mask is molded from the same material as theoptic (e.g., a liquid acrylic or silicone material) at the same generaltime and/or such that the mask and optic undergo similar curingsequences (e.g., the mask and optic can be at least partially curedtogether). For example, the mask can be formed from a liquid materialthat has been modified to be substantially opaque by mixing in a darkpigment dye or dark particles, whereas the optic can be formed from theunmodified transparent liquid material. In this type of manufacturingprocess, however, mixing, bleeding, and/or blending can occur betweenthe opaque mask material and the transparent optic material. If thisoccurs, the outer and inner diameter borders of the mask can becomeblurred and/or diffuse. This can negatively impact the opticalperformance of the intraocular lens.

This mixing, bleeding, and/or blending of the opaque and transparentliquid materials can be reduced or prevented by providing a mask-formingfeature in the lens mold which can help prevent the opaque material fromspreading beyond the desired region where the mask is to be formed onthe surface of the optic or within the optic. In some embodiments, themask-forming feature can be an annular trough formed in the lens mold atthe location where the mask is to be positioned. This mask-formingtrough can have inner and outer diameters, which correspond to thedesired size of the mask. The opaque material used to form the mask canbe added to fill this trough. Transparent material used to form theoptic can be added over or around the opaque material in themask-forming trough. The trough can help to prevent the opaque materialfrom mixing, bleeding, and/or blending with the transparent material ina way that would blur the outer or inner diameter of the mask. Thetrough can achieve this, for example, through surface tension, whichhelps to hold the opaque material in place. In this way, more precisemask borders can be achieved. For example, the inner border line of themask (which defines the central circular aperture 2038) and the outerborder line of the mask (which defines the outer circular perimeter ofthe mask 2034) can each be circular to within ±100 microns (e.g., anylocation along the inner or outer border of the mask can be within 100microns of a perfect circle [or within 75 microns, or within 50 microns,or within 25 microns]). In addition, the outer border and the innerborder can be concentric to within f 200 microns (e.g., the outer borderand the inner border at any given angular position can be within 200microns of being perfectly concentric [or within 150 microns, or within100 microns, or within 50 microns]).

When forming an intraocular lens with the mask positioned on an anterioror posterior surface of the optic, a lens forming surface of the lensmold can include a mask-forming feature located at a position where themask is to be formed. The mask-forming feature can be generally annularand defined by an outer edge and an inner edge. These edges can be sharpknife edges in order to more effectively hold the opaque mask materialin place via surface tension. The lens forming surface can also includean optic region positioned radially inward and/or outward of themask-forming feature. As just mentioned, the mask-forming feature can bean annular trough. This trough can be etched, machined, or otherwise cutinto the lens forming surface of the lens mold. The trough can have aminimum depth that creates a mask thickness which provides less than 5%light transmission (or less than 3% or less than 2%). In someembodiments, the depth of the trough can be at least about 4 microns, orbetween about 5 microns and about 10 microns. But the trough can be asdeep as practically appropriate without causing dissimilar materialproperty interactions between the mask material and the optic material,resulting in poor injection performance (e.g., a maximum trough depth ofabout 150 microns).

The optic region of the lens forming surface of the mold will generallybe curved in order to provide the intraocular lens with refractiveoptical power. In such embodiments, the mask-forming feature can have adifferent radius of curvature than the optic region. This difference inradius of curvature can result in a trough in the lens forming surfaceto create the mask-forming feature and facilitate the creation of aprecise border between the mask and the optic. The radius of curvatureof the mask-forming feature can be between about 25% and about 50% ofthe radius of the optic region, such as between about 25% and 35%,between about 30% and about 40%, between about 35% and about 45%,between about 40% and about 50%, or otherwise. In some implementations,the radius of curvature of the mask-forming feature can be between about30% and about 35% of the radius of the optic region, such as about 32%.In other embodiments, however, the mask-forming feature and the opticregion can have the same radius of curvature, but can be separated by astepped transition.

FIG. 5 is a flow chart illustrating a method of manufacturing anintraocular lens with a mask positioned on the anterior or posteriorside of the optic. The method can include preparing a mixture of uncuredmask material (e.g., an acrylic copolymer or silicone) mixed orimpregnated with a high density of carbon black particles or other blackdye or pigments as needed to provide opaque properties (e.g., to permitno more than about 2% light transmission). A specific and precise volumeof uncured opaque mask material can be dispensed (e.g., with a cannula)to fill the mask-forming feature and define an outer diameter and aninner diameter of the mask (block 1050). By relying on surface tensionand capillary action of the viscous mask material, the dispensed volumecan be specifically controlled to conform to the outer and inner edgesof the mask-forming feature of the mold. The exposed surface of theuncured mask material (i.e., opposite the lens forming surface) canexhibit a curvature. To achieve these results, the mask material canhave a viscosity and/or surface tension that can range fromapproximately that of water to acetic acid per as specified below:

Absolute Viscosity Surface Tension Fluid (N s/m², Pa s) (cp) (10⁴lb_(m)/ft sec) mN/m Acetic acid 0.0011550 1.155 7.760 27.60 @ 20 C.Water 0.0008900 0.890 6.000 71.95 @ 25 C.

After filling the mask-forming feature, the mask can optionally bepartially or fully cured using, for example, a combination of UV lightand heat cycles (block 1052). Thereafter, the mold can be filled with anoptically transmissive optic material, which may be the same as the maskmaterial (e.g., acrylic or silicone), to over-mold the mask (block1054). Finally, the mask material and the optic material can be fullycured—again, using a combination of UV light and heat cycles (block1056).

In an alternative embodiment, the intraocular lens may be manufacturedwith the mask embedded within the optic. The method can include at leastpartially filling a first mold portion with an uncured optic material(block 1060). The first mold portion can be filled up to the depth wherethe mask is to be formed in the interior of the optic. In this way, theoptic is initially only partially formed just to the thickness where themask will be embedded in the completed optic. In this case, the firstmold portion need not include a mask-forming feature. Instead, a secondmold portion, which mates with the first mold portion, can include astructure that is the physical complement of the desired mask-formingfeature. For example, the second mold portion can include an annularprojection located where the mask is to be formed. The annularprojection will form a trough in the partially-formed optic. Asdiscussed further below, after at least partial curing of the opticmaterial in the first mold portion, this trough in the partially-formedoptic becomes the mask-forming feature and can be filled with opaquemask material.

After the first and second mold portions are mated together, the uncuredtransparent optic material can be partially or fully cured to form atrough in the interior surface of the partial optic (block 1062). Thetrough in the partial optic can be filled with an opaque mask material(block 1064). The opaque mask material can be prepared, for example, bymixing or impregnating an optically transmissive mask material (e.g., anacrylic copolymer or silicone) with a high density of carbon blackparticles or other black dye or pigments as needed to provide opaqueproperties (e.g., to permit no more than about 2% light transmission). Aspecific and precise volume of uncured opaque mask material can bedispensed (e.g., with a cannula) to exactly fill the trough in thepartial optic and define an outer diameter and an inner diameter of theannular mask. By relying on surface tension and capillary action of theviscous mask material, the dispensed volume can be specificallycontrolled to conform to the outer and inner edges of the trough in thepartial optic. The exposed surface of the uncured mask material (i.e.,opposite interior surface of the optic) can exhibit a curvature. Afterfilling the trough in the partial optic, the mask can optionally bepartially or fully cured (block 1066). Thereafter, the mold can befilled with additional optic material to over-mold the mask (block1068). A third mold portion can be used in place of the second moldportion to form an outer surface of the optic. Finally, the maskmaterial and the optic material can be fully cured (block 1070). In someimplementations, one of the mold portions may include a protruding pinthat defines the inner diameter of the mask-forming feature and radiallycenters the mask in the optic.

An alternative method of manufacturing an intraocular lens with anembedded mask is illustrated in FIG. 7 and FIGS. 9A-9F. A measuredpartial volume of liquid type uncured optic material 2060 can be placedin a mold half 2062 a (block 1080 and FIG. 9A). An edge borderdelineator 2050 can be placed on the center of the liquid optic material2060 (block 1082 and FIG. 9B). A bead of opaque mask material 2064 canbe dispensed within the lines of the edge border delineator 2050 (block1084). The opaque mask material 2064 wicks to the confinements of theedge border delineator 2050 (FIG. 9C). Optionally, a bead of uncuredoptic material 2060 can be dispensed within the central aperture of theedge border delineator 2050 (FIG. 9D). The bead of optic material 2060wicks to the inner periphery of the edge border delineator. At least thesurface of the optic material 2060 can be partially cured at this time(block 1086). A measured partial volume of uncured optic material 2060can be placed into the opposite mold half 2062 b (block 1088). The twomold halves 2062 a, 2062 b can then be joined together and theintraocular lens can be put through the full curing process (block 1090and FIG. 9E). Thereafter, the intraocular lens can be removed from themold (FIG. 9F).

FIG. 8A illustrates an embodiment of the edge border delineator 2050.The edge border delineator 2050 can include an outer border 2052 spacedapart from an inner border 2054. As explained above, the opaque maskmaterial can be dispensed between the outer border 2052 and the innerborder 2054. The bead of optic material can be dispensed radially inwardof the inner border 2054. The edge border delineator 2050 can be madefrom compatible polymer or elastic type polymer material (e.g., anacrylic copolymer or silicone). A width of the inner and/or outer border2054, 2052 (e.g., in a radial direction) can be within a range of 100microns to 500 microns. The thickness of the inner and/or outer border2054, 2052 (e.g., in an anterior-posterior direction) can be betweenabout 5 and 15 microns thick with a flat formed shape. Connecting spokes2056 may or may not be used to maintain inner and outer borderconcentricity (see FIG. 8B). The cross-sectional profile of the innerand/or outer border 2054, 2052 can be vertical, stair stepped (see FIG.8C), sloped (see FIG. 8D), fully contained (see FIG. 8E), or any otherprofile to facilitate the wicking/capillary action of the liquid acrylicas necessary. A plurality of mechanical locking holes can be provided inthe edge border delineator to support capillary action and to minimizedelamination of the intraocular during injection.

Terminology

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements, and/or steps areincluded or are to be performed in any particular embodiment.

The terms “comprising,” “including,” “having,” and the like aresynonymous and are used inclusively, in an open-ended fashion, and donot exclude additional elements, features, acts, operations, and soforth. Also, the term “or” is used in its inclusive sense (and not inits exclusive sense) so that when used, for example, to connect a listof elements, the term “or” means one, some, or all of the elements inthe list.

The terms “approximately” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately,” “about,” and “substantially” may refer to an amountthat is within less than 10% of the stated amount, as the context maydictate.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between” and the like includes thenumber recited. Numbers preceded by a term such as “about” or“approximately” include the recited numbers. For example, “about 3 mm”includes “3 mm.”

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of themethods and IOLs shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure. Awide variety of designs and approaches are possible. No feature,structure, or step disclosed herein is essential or indispensable.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the disclosure may be embodied or carried out in a mannerthat achieves one advantage or a group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

Moreover, while illustrative embodiments have been described herein, thescope of any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. The limitations in theclaims are to be interpreted broadly based on the language employed inthe claims and not limited to the examples described in the presentspecification or during the prosecution of the application, whichexamples are to be construed as non-exclusive. Further, the actions ofthe disclosed processes and methods may be modified in any manner,including by reordering actions and/or inserting additional actionsand/or deleting actions. It is intended, therefore, that thespecification and examples be considered as illustrative only, with atrue scope and spirit being indicated by the claims and their full scopeof equivalents.

1. A method of manufacturing an intraocular lens, the method comprising:filling an annular mask-forming feature with an opaque mask material;adding optically transmissive optic material over the opaque maskmaterial; and fully curing the opaque mask material and the opticallytransmissive optic material to form a mask and an optic, the mask beingsufficient to prevent transmission of at least 90% of incident visiblelight.
 2. The method of claim 1, wherein the annular mask-formingfeature is provided in a portion of a lens mold.
 3. The method of claim1, wherein the annular mask-forming feature is provided in apartially-formed optic.
 4. The method of claim 3, further comprising,prior to filling the annular mask-forming feature with opaque maskmaterial, forming the partially-formed optic by at least partiallycuring a dose of the optically transmissive optic material in a portionof a lens mold.
 5. The method of claim 1, further comprising preparingthe opaque mask material by mixing an optically transmissive materialwith an opaque agent.
 6. The method of claim 5, wherein the opticallytransmissive material comprises acrylic.
 7. The method of claim 5,wherein the opaque agent comprises carbon black.
 8. The method of claim1, further comprising at least partially curing the opaque mask materialbefore adding the optically transmissive optic material over it.
 9. Themethod of claim 8, wherein at least partially curing the opaque maskmaterial comprises fully curing the opaque mask material.
 10. The methodof claim 1, wherein the mask is sufficient to prevent transmission of atleast about 98% of incident visible light.
 11. The method of claim 1,wherein the opaque mask material and the optically transmissive opticmaterial comprise the same material.
 12. The method of claim 11, whereinthe same material comprises acrylic.
 13. The method of claim 1 wherein asurface of the annular mask-forming trough has a radius of curvaturethat is about 25% to about 50% of a radius of curvature of the optic.14. The method of claim 13, wherein the radius of curvature of thesurface of the mask-forming trough is between about 30% and about 35% ofthe radius of curvature of the optic.
 15. The method of claim 1, whereinthe optic is monofocal.
 16. The method of claim 1, wherein the annularmask-forming feature comprises a trough.
 17. The method of claim 1,wherein the annular mask-forming feature comprises a border delineator.18. An intraocular lens formed by the method of claim 1.